REDI-RELEASE ABSORBENT DRESSING— 510(k) K904604

Name: FDA 510(k) clearance K904604
Creator: U.S. Food and Drug Administration
Published: 1991-01-07

Substantially Equivalent

Fountain Pharmaceuticals, Inc.

FDA 510(k) clearance K904604 for REDI-RELEASE ABSORBENT DRESSING, Substantially Equivalent on 1991-01-07. Applicant: Fountain Pharmaceuticals, Inc.. Device class: 1.

Clearance details

Applicant: Fountain Pharmaceuticals, Inc.
Product code: Code KOZ
Device class: Class 1
Regulation: 21 CFR 878.4018
Advisory panel: General, Plastic Surgery
Date received: 1990-10-10
Decision date: 1991-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KOZ

product code KOZ

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.